Anastomosis device having improved tissue presentation

ABSTRACT

In accordance with the present invention there is provided a surgical device for presenting a first hollow organ and a second hollow organ for creation a passageway therebetween. The surgical device includes a member, an upper pin for entering a first hollow organ, and a lower pin for entering a the second hollow organ, the pins having proximal ends attached to the member, distal ends extending therefrom and longitudinal axis extending therebetween. The device further includes a first actuator assembly coupled to the member for laterally moving the distal and proximal ends of the lower pin relative to the first member, and a second actuator coupled to the member for moving the distal ends of the upper and lower pins adjacent to one another so as to move the hollow organs close together.

FIELD OF THE INVENTION

The present invention relates, in general, to devices and methods thatfacilitate the anastomosis of hollow organs of the body. Moreparticularly, it relates to vascular anastomosis devices incorporatingsutures for joining a graft blood vessel to a target blood vessel suchas the aorta or coronary artery.

BACKGROUND OF THE INVENTION

Surgically forming a passage between lumens of two normally distinctorgans is a critical part of many surgical procedures. In a coronaryartery bypass graft (CABG) procedure, the surgeon uses a graft vesselharvested from the patient to connect a blood supply vessel such as theaorta to the diseased coronary artery on the heart. An anastomosis ismade on both the distal and proximal ends of the graft vessel. Surgeonstypically use the saphenous vein of the leg or the radial artery of thearm or both, in multiple bypass cases. In an alternative procedure, theinternal mammary artery (IMA) is used as a graft vessel. In thisprocedure the IMA is temporarily clamped, severed at a location allowingenough length to be redirected towards the heart, dissected from thechest wall and arterial side branches, and then the distal end (pedicle)is sutured to the left anterior descending coronary artery (LAD) toimprove or restore blood flow to the left ventricle of the heart.

For the grafting procedures mentioned above, the surgeon performs anend-to-side type of vascular anastomosis. That is, the surgeon attachesthe open end of the graft vessel to the side of the target vessel.However, surgeons also perform other types of anastomoses. Surgeonscommonly use an end-to-end type of anastomosis for joining togetherlarger hollow organs such as bowel, and for some heart bypass procedureswhere the arterial flow is completely occluded by the stenosis in thediseased artery.

Some surgeons choose to complete all the proximal anastomoses to theaorta before commencing the distal anastomoses to the coronary arteries.In contrast, others choose to complete the distal anastomoses first.Regardless of the order, when undertaking a distal anastomosis to thecoronary artery, it is important to atraumatically hold the vessel graftsteady and adjacent the coronary artery, with a minimum of visual andsurgical obstruction by instruments in the narrow operative field.

Currently surgeons perform each vascular anastomosis by hand suturingwith a tiny, curved needle and very fine suture filament. Such asuturing method, however, is very time consuming and requires severalminutes per anastomosis, even for an experienced surgeon. In some casesthe blood flow in the newly joined vessels may be poor, and the surgeonmust remove the stitches and repeat the suturing procedure. In surgicalprocedures involving multiple bypass grafts, the total time required forsuturing is very substantial, putting the patient at risk and increasingthe cost of the surgical procedure.

In a preferred type of suturing method for the anastomosis of bloodvessels, the surgeon passes a needle through the wall of the firstvessel (such as the coronary artery) from the inside to the outside, andthen passes it from the outside to the inside of the second vessel (suchas the graft vessel), so that when the suture is drawn tight, the insidewalls of the vessels come together, intima-to-intima. This is to ensurethat the vessels heal together properly with a smooth layer ofendothelial cells formed on the inside of the anastomosis. The surgeontypically places a single stitch in this manner at each of the heel andtoe locations of the anastomosis, and then makes a running stitch oneach half of the anastomosis between the heel and toe.

For the standard CABG procedure, the surgeon accesses the heart througha median sternotomy in which the rib cage is split longitudinally on themidline of the chest, and the left and right rib cages are spread apart.In recent years, surgeons have been using other means of access to theheart to reduce the size of the surgical wound created. In a surgicalprocedure known as a MIDCAB (Minimally Invasive Direct Coronary ArteryBypass), the surgeon accesses the heart by using a small, leftthoracotomy (incision between the ribs on the left chest) directly abovethe heart. In this procedure, the surgical opening and visibility of theheart are significantly reduced, and hand suturing is more difficultthan when using a median sternotomy. Other new developments in thesurgical procedures have made conventional suturing even more difficult.For example, some surgeons now perform bypass surgery on beating heartsto avoid the complications associated with using a heart lung bypassmachine.

The literature contains disclosures of a number of devices foraugmentation of the suturing techniques. These devices attempt withvarying degrees of success to reduce the difficulty in repeatedlypassing a needle and thread through the vascular walls. Examples includethe following: U.S. Pat. No. 5,571,090 issued to Sherts on Nov. 5, 1996;U.S. Pat. No. 4,803,984 issued to Narayanan on Feb. 14, 1989; and U.S.Pat. No. 5,545,148 issued to Wurster on Aug. 13, 1996. However, thesedevices have a number of disadvantages. In Sherts and Narayanan, theindividual stitches must be made one at a time and therefore theprocedure is still tedious and time consuming. The working ends of theWurster and Sherts devices appear to obstruct the view of the needle tipso precise placement of the stitch might be difficult in somesituations.

When suturing tiny blood vessels together, the surgeon must minimizemanipulation of the graft and the target vessels to prevent damagingthem. This ensures that the vessels heal together properly and a smoothpassage between them is created. Usually in a conventional bypassprocedure the surgeon applies a surgical clamp upstream (proximal) tothe anastomotic location on the coronary artery to stop blood flowthere. Applying surgical clamps may injure the artery and compromise thelong term viability of the vessel to maintain blood flow. Applyingsurgical clamps may also dislodge plaque adhered on the intima of thelumen of the diseased vessel, creating emboli that could migrate intothe systemic circulation and seriously injure or kill the patient.

An example of a device which simplifies the anastomosis procedure forthe physician is shown in U.S. Pat. No. 6,015,416 issued to Stefanchiket al on Jan. 18, 2000 (hereinafter Stefanchik), which is herebyincorporated herein by reference. Stefanchik discloses a handheld,surgical device that addresses the aforementioned considerations. Thedevice in Stefanchik facilitates a sutured anastomosis of very smallhollow organs such as blood vessels while maintaining blood flow in thevessels. The device in Stefanchik comprises a first member having afirst prong for entering a first vessel and a second prong for enteringthe wall of a second vessel. The device further comprises a secondmember having a plow for incising at least one of the vessels so as tocreate a passageway between the vessels. A frame is provided forcoupling the first member and the second member together in operationalengagement. The second member further includes a plurality of needlepaths on either side of the plow for guiding a pair of helical needleswith attached sutures through the walls of the vessels on either side ofthe passageway. The device also includes a means for driving the helicalneedles so as to attach the vessels together. The device in Stefanchikrequires minimal manipulation of the blood vessels and joins the vesselstogether intima-to-intima. The device in Stefanchik may be used duringtraditional, open cardiac procedures (CABG) as well as in minimallyinvasive procedures such as MIDCAB procedures.

A shortcoming of the device in Stefanchik is the conventional type ofattachment between the suture filament and the helical needle. Thesuture filament used is a size 7-0 propylene monofilament, and is swageddirectly to the stainless steel needle without any kind of strainrelieving interface. As each helical needle rotates through the vesselwalls, the suture filament twists and pulls at the needle attachment andrisk of suture filament breakage is significant. What is needed is astress relieving interface at the needle-suture attachment.

Although stress relieving interfaces are widely used in the electronicsindustry for attachment of connectors to wires or cords, the novelapplication of stress relieving interfaces to surgical needle-sutureattachments has not been available prior to the present invention.Several references are available describing inventions for controlledsuture release so that the needles may be pulled off the suture byapplying forces in relatively uniform and consistent ranges. Examples ofcontrolled release sutures are the following: U.S. Pat. No. 4,124,027issued to Boss on Nov. 7, 1978; U.S. Pat. No. 5,089,010 issued toKorthoff on Feb. 18, 1992; and U.S. Pat. No. 5,403,345 issued toSpingler on Apr. 4, 1995. However, these inventions and the others citedin the references are designed specifically for lowering the forcerequired to separate the needle from the suture. There are no referencesthat describe devices or methods for preventing suture breakage at thesuture-needle attachment when the suture is highly stressed due totwisting and pulling at the needle attachment.

A second shortcoming of the device disclosed in Stefanchik is poorvisibility of one of the two hollow organs being joined together.Stefanchik describes placement of a first prong for entering a wall of afirst hollow organ (for example, a graft vessel) and a second prong forentering the wall of a second hollow organ (for example, a coronaryvessel on the heart). The second prong is attached to an implement,which obstructs the view of the second hollow organ while the secondprong is placed into the wall of the second hollow organ. What is neededis a means for retracting the implement apart from the second prong sothat the operator has improved visibility of the second hollow organduring placement of the second prong into the wall of the second holloworgan.

A third shortcoming of the device disclosed in Stefanchik is the ease ofremoving the two needles from the implement after the stitches are madeto join the two hollow organs together, and for drawing the two suturesthrough the two hollow organs to provide enough free length of suturefor tying a knot to complete the anastomosis. For the device inStefanchik, it is necessary to use a surgical grasping tool to graspeach needle, release it from the implement, and pull directly on theneedle to draw suture through the two hollow organs. Since the needlesare very small and partially obstructed by the implement, it may bedifficult for the operator to easily grasp the needle in this manner,especially during an endoscopic surgical procedure. What is needed is aneedle receiver for each needle within the element, so that at the endof the actuation of the device in Stefanchik, the needle receiver may begrasped easily by a surgical grasping tool and withdrawn from theimplement of the device while pulling the suture attached to the needleto provide a sufficient length of suture for knot tying.

For the device in Stefanchik, it is necessary that the implement betemporarily attached to a bodily organ, such as the heart, during theoperational sequence of the device and that the drive unit for drivingthe implement be handheld by an operator during the procedure. Anotherdesirable refinement to the device in Stefanchik would be to use acommercially available, sheathed cable particularly adapted fortransmitting rotational and translational force from a drive unit to theimplement of the device. By using a commercially available, sheathedcable, the cost to manufacture the surgical device could be reduced.Improving efficiency of force transfer would allow smoother and easieroperation of the surgical device.

SUMMARY OF THE INVENTION

In accordance with the present invention there is provided a surgicaldevice for presenting a first hollow organ and a second hollow organ forcreation a passageway therebetween. The surgical device includes amember, an upper pin for entering a first hollow organ, and a lower pinfor entering a the second hollow organ, the pins having proximal endsattached to the member, distal ends extending therefrom and longitudinalaxis extending therebetween. The device further includes a firstactuator assembly coupled to the member for laterally moving the distaland proximal ends of the lower pin relative to the first member, and asecond actuator coupled to the member for moving the distal ends of theupper and lower pins adjacent to one another so as to move the holloworgans close together.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. The invention itself, however, both as toorganization and methods of operation, together with further objects andadvantages thereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is an isometric view of the present invention, a surgical device10;

FIG. 2 is an isometric view of a head assembly 100 and a handle 500 ofsurgical device 10 shown in FIG. 1;

FIG. 3 is an exploded isometric view of head assembly 100 and handle 500shown in FIG. 2;

FIG. 4 is a side view of a drive unit 600 shown in FIG. 1, with aportion of drive unit shell 610 removed to reveal the internalcomponents;

FIG. 5 is a side view in partial section of a left drive cable 608,which operationally engages with drive unit 600 shown in FIG. 1;

FIG. 6 is an isometric view of left drive cable 608 shown in FIG. 5;

FIG. 7 is an exploded isometric view of head assembly 100 shown in FIG.1;

FIG. 8 is an exploded isometric view of a right roller assembly 170,which is part of head assembly 100 shown in FIG. 7;

FIG. 9 is an exploded isometric view of right roller assembly 170 shownin FIG. 8, with a right leaf spring 190 and a right spring plate 192shown in closer alignment with a right roller 196;

FIG. 10 is an isometric view of right roller assembly 170 shown with aplow 290 and a left helical needle 261;

FIG. 11 is an exploded isometric view of a right tissue holder 330,which is part of head assembly 100 shown in FIG. 7;

FIG. 12 is an isometric view of right tissue holder 330, right rollerassembly 170, and a right frame 146 shown in alignment prior toassembly;

FIG. 13 is an isometric view of right tissue holder 330, right rollerassembly 170, and right head frame 146 shown assembled;

FIG. 14 is a cross-sectional view of head assembly 100 taken throughline 14—14 in FIG. 2;

FIG. 15 is an exploded isometric view of an upper pin assembly 430,which is part of head assembly 100 shown in FIG. 7;

FIG. 16 is an isometric view of assembled, upper pin assembly 430 shownin FIG. 15;

FIG. 17 is an exploded isometric view of a lower pin assembly 460;

FIG. 18 is an isometric view of assembled, lower pin assembly 460 shownin FIG. 17;

FIG. 19 is a side sectional view of head assembly 100 taken at line19—19 in FIG. 14, showing an upper tissue pin 360 inserted into a firstvessel 702, and a lower tissue pin 440 inserted into a second vessel704, and with lower pin assembly 460 spaced apart from head assembly100;

FIG. 20 is the same view as shown in FIG. 19, but with lower pinassembly 460 spaced near head assembly 100;

FIG. 21 is the same view as FIG. 20, but with an upper pin assembly 430adjusted so that first vessel 702 is approximately parallel and close tosecond vessel 704;

FIG. 22 is the same view as FIG. 21, but with a plow blade 298 shownadvanced through first vessel 702 and second vessel 704;

FIG. 23 is the same view as FIG. 22, but with a left helical needle 261shown rotated through a portion of first vessel 702 and second vessel704, and with a left suture 281 trailing to create a plurality of leftsuture stitches 708;

FIG. 24 is a sectional view of head assembly 100 taken at line 24—24 inFIG. 23;

FIG. 25 is the same view as FIG. 23, but with helical needle 261 fullyadvanced and ready for removal from head assembly 100;

FIG. 26 is a top view of head assembly 100 for when left helical needle261 is in a start position;

FIG. 27 is a top view of head assembly 100 and is shown with a surgicaltool 800 removing a left needle receiver 333 containing left helicalneedle 261;

FIG. 28 is a top view of head assembly 100 with a right head frame 146and a left head frame 147 shown in an open position for removing headassembly 100 from first vessel 702 and second vessel 704;

FIG. 29 is a top view of first vessel 702 joined to second vessel 704 bya plurality of right suture stitches 706 and plurality of left suturestitches 708;

FIG. 30 is the same view as FIG. 29, but with a proximal knot 712 and adistal knot 710 partially tied;

FIG. 31 is a side sectional view of a portion of a prior art needle 670shown attached in a conventional manner to a prior art suture 672; and

FIG. 32 is a side sectional view of a portion of left helical needle 261of the present invention shown attached to left suture 281, andassembled with a stress relieving element 674.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description of the present invention, theapplicants provide a description of how the invention is used to createa modified end-to-side anastomosis between two blood vessels. Thepresent invention may also be used to create conventional end-to-side,side-to-side and end-to-end anastomoses, and is not limited to onlyblood vessels, but may be used also for joining other types of holloworgans.

Referring now to the drawings wherein like numerals indicate the sameelement throughout the views, there is shown in FIG. 1 a preferredembodiment of the present invention, a surgical device 10. Device 10generally comprises a handle 500, a head assembly or member 100, shownin a first position, and a drive unit 600. Head assembly 100 isoperationally connected to handle 500 by a block assembly 132, whichslides along a right rail 490 and a left rail 491 affixed to handle 500.A lower pin assembly 460, or arm, is attached to right rail 490 and leftrail 491. Handle 500 includes a first actuator 506 and a second actuator562. Drive unit 600 operationally connects to head assembly 100 by aright drive cable, or flexible rotatable member, 606 and a left drivecable, or flexible rotatable member, 608. Drive unit 600 includes athird actuator 602 and a fourth actuator 604, which is rotatable only inone direction.

FIG. 2 is an isometric view of head assembly 100 in the first positionand handle 500. When an operator completely depresses first actuator 506on handle 500, head assembly 100 laterally moves to a second positioncloser to lower pin assembly 460 and member 100 and locks into place.When an operator depresses second actuator 562 on handle 500, headassembly 100 returns to the first position. Head assembly 100, blockassembly 132, and lower pin assembly 460 also comprise what is referredto as a working portion 20 of the present invention.

FIG. 3 contains an exploded isometric view of the components of handle500, and includes head assembly 100 and lower pin assembly 460 separatedfrom handle 500. Right rail 490 and left rail 491 fixedly attach to aright rail hole 468 and a left rail hole 467, respectively, of lower pinassembly 460. Left rail 491 slidably passes through a left block hole110 of block assembly 132 and into a left collar hole 578 of a collar570. A left collar screw 584 screws into collar 570 and attaches leftrail 491 to collar 570. Similarly, right rail 490 slidably assemblesinto block assembly 132 and fixedly attaches to a right collar hole 576of collar 570 by a right collar screw 582. Handle 500 further includes arod 536 for moving head assembly 100 up and down. A return spring 544assembles over rod 536 and bears against a flange 538 as shown in aphantom view of return spring 544. Return spring 544 also pushes againsta spring ledge 550 in a second handle half 504, thus tending to urge rod536 in the proximal (upward) direction. Rod distal end 532 passesthrough a collar opening 580 and pivotally attaches to head assembly 100by insertion of a block pin 109 through a block hole 108 and a rod hole534 of rod 536 (pivot assembly). A wedge element 522 is pivotallyattached to a bushing 530 connected to rod 536 by a wedge pin 526inserted through a bushing hole 528 and a wedge hole 524. When anoperator presses a first surface 518 of first actuator 506, wedgeelement 522 is pushed in the distal (downward) direction to move headassembly 100 closer to lower pin assembly 460. First actuator 506includes a first axle 508 for pivoting in a first axle recess 512 insecond handle half 504. First actuator 506 also includes a first stoppost 510 that limits the travel of first actuator 506 by hitting a firststop recess 514 in first handle half 504. Rod 536 reciprocateslongitudinally in a lower bearing surface 529, a middle bearing surface554, and a upper bearing surface 548 of second handle half 504. Theproximal end of rod 536 is adapted with a hook 542 for engaging with alatch 546 in second handle half 504 so that head assembly 100 may beheld in the second position when first actuator 506 has been fullydepressed. Rod 536 is released by depressing second actuator 562 havinga latch release arm 564 that disengages latch 546 from hook 542, thusallowing head assembly 100 to return to the first position. A firsthandle half 502 attaches to second handle half 504 by any one ofnumerous fastening means well known in the art, and a handle fastenerhole 560 is provided in the proximal end of second handle half 504. Afirst and a second distal end half, 552 and 554, of first and secondhandle halves, 502 and 504, are held together within collar opening 580and to block assembly 132 by a collar pin 574 passing through a collarpin hole 572 of collar 570, and engaging with a collar pin slot 503 infirst handle half 502. When handle 500 is fully assembled, firstactuator 506 protrudes through a first actuator opening 516 of firsthandle half 502, and second actuator 562 protrudes through a secondactuator opening 566 of first handle half 502.

As will be apparent to those skilled in the art, all of the componentsof handle 500 may be constructed of materials and using methods so thatit would be practical for handle 500 to be either single patient usedisposable or reusable after sterilization in a steam autoclave such asused in hospitals.

FIG. 4 is a side view of drive unit or needle driver 600 with a portionof a drive unit shell 610 removed to reveal the internal components.Third actuator 602 has a first extension 613 for engaging a firstconnector 612, which is fixedly attached to right shaft 649 of rightdrive cable 606. Third actuator 602 has a second extension 615 forengaging a second connector 614, which is fixedly attached to left shaft650 of left drive cable 608. An operator may slide third actuator 602 ineither longitudinal direction in a translation slot 617 of drive unitshell 610. When an operator slides third actuator 602 in a proximaldirection (left), first and second shafts, 649 and 650, translate in thedistal (left) direction. When an operator slides actuator 602 in aproximal direction, first and second shafts, 649 and 650, translate in aproximal (right) direction.

Still referring to FIG. 4, fourth actuator 604 of drive unit 600 isrotatably attached to a main gear 620, which meshes with a first shaftgear 618, which in turn meshes with a second shaft gear 619. When anoperator rotates fourth actuator 604 in a clockwise direction, firstshaft gear 618 rotates in a counter clockwise direction, and secondshaft gear 619 rotates in a clockwise direction. As a consequence, rightshaft 649 rotates in a counter clockwise direction, and left shaft 650rotates in a clockwise direction. To simplify operation of drive unit600, a one way rotation mechanism is preferably included, although notshown in FIG. 4, in drive unit 600 to allow rotation of rotation knob604 to occur only in the clockwise direction. Such a one way rotationmechanism is disclosed in related patent U.S. Pat. No. 6,015,416. Afirst shaft drive end 622 has a non-circular cross section and fitsslideably into first shaft gear 618, so that right shaft 649 may berotatably driven by first shaft gear 618, yet be free to translatelongitudinally. A second shaft drive end 624 also has a non-circularcross section and fits slideably into second shaft gear 619, so thatleft shaft 650 may be rotatably driven by second shaft gear 619, yet befree to translate longitudinally.

Those skilled in the art will recognize that drive unit 600 may be madeof materials and using methods so that drive unit 600 may be eithersingle patient use disposable or sterilzable in hospitals for multiplepatient use.

FIG. 5 is a side sectional view of the distal portion of left drivecable 608. The distal portion of right drive cable 606 is identical tothat of left drive cable 608. Left shaft 650 is attached to a left driveconnector 652 having a drive connector bore 658. An inner spring 655,preferably in compression, made of spring wire surrounds left shaft 650and is covered by a sheath 654, preferably in tension, made of a wiremesh or braided wire. Inner spring 655 and sheath 654 are attached to aferrule 660 having a pair of ferrule indentations 656 for retention inhead assembly 100 (see FIG. 19). Right and left drive cables, 606 and608, are flexible but have minimal shape memory and do not elongate whentensioned during usage. Preferably, drive cables 606 and 608 have theability to transmit rotation and/or translation without kinking orelongation. A particularly suitable sheathed cable for right and leftdrive cables, 606 and 608, is a flexible camera cable for a remoteshutter actuator, available from Brandess-Kalp Aetna Group, 701Corporate Woods Parkway, Vernon Hills, N.J. 60061.

FIG. 6 is an isometric view of the distal portion of left drive cable608 shown in FIG. 5. In this view it can be seen that connector bore 658is non-circular so that left drive cable 608 can transmit a rotationalforce from drive unit 600 to head assembly 100 shown in FIG. 3. Apushing surface 661 on left drive connector 652 permits left drive cable608 to transmit a translational force from drive unit 600 in the distaldirection to head assembly 100. Right drive cable 606 (see FIG. 4) isconfigured similarly also to transmit rotational and translationalforces from drive unit 600 to head assembly 100.

FIG. 7 is an exploded, isometric view of several components of theworking end (tissue contacting portion) of the present invention andgenerally includes head assembly 100 and block assembly 132. Headassembly 100 further includes an upper pin assembly 430, a right tissueholder 330 having a right needle receiver 339, a left tissue holder 331having a left needle receiver 333, a right roller assembly 170, a leftroller assembly 171, a plow 290, a right frame 146, and a left frame147. Right roller assembly 170 further includes a right roller housing172, a right leaf spring 190, a right roller plate 192, a right roller196 (having a plurality of annular rings disposed thereon), a rightneedle guide 220 and right helical needle 260 having a right suture 280attached to it. Left roller assembly 171 further includes a left rollerhousing 173, a left leaf spring 191, a left roller plate 193, a leftroller 197 (having a plurality of annular rings disposed thereon), aleft needle guide 221, and a left helical needle 261 having a leftsuture 281 attached to it. Right and left sutures, 280 and 281, arepreferably made from a polypropylene monofilament, size 7-0 (0.003 in.),as is typically used for sewing together blood vessels for a coronaryartery bypass graft procedure. The above assembly being one example of ameans for two hollow organs about a passageway therebetween. Theremaining components shown in FIG. 7 are preferably made from stainlesssteel using numerous well-known manufacturing techniques includinginjection molding of stainless steel.

Still referring to FIG. 7, block assembly 132 includes a block 102generally for mounting head assembly 100 to handle 500 as shown in FIG.3. Block 102 has a support wall 114 having a support face 116 configuredfor aligning and supporting left and right frames, 147 and 146, of headassembly 100. A right frame ledge 152 on a right turret 148 of rightframe 146 fits closely onto a support face edge 117 of support face116.A left turret 149 of left frame 147 also fits closely onto supportface edge 117. Support face 116 has a right roller hole 118, whichprovides access for right drive cable 606 (not shown) to connect toright roller 196. A left roller hole 119 similarly provides access forleft drive cable 608 (not shown) to connect to left roller 197. Supportface 116 has a smaller, central hole 122 for left and right sutures, 280and 281, to exit head assembly 100. An assembly pin hole 124 in supportface 116 retains a clamp pin 128.

FIG. 7 also shows a clamp 137 of block assembly 132 having a clampopening 135, which fits over right and left turrets, 148 and 149, ofright and left frames, 146 and 147. Clamp 137 comprises a right clampelement 142 and a left clamp element 144 attached to a clamp spring 140,preferably by welding, so that right and left clamp elements, 142 and144, are normally sprung apart in an open position. Right turret 148 isattached, preferably by welding, to right clamp element 142. Left turret149 is attached, preferably by welding, to left clamp element 144. Whenclamp 137 is normally sprung apart, right frame 146 and left frame 147are sprung apart in a vee-shaped configuration as shown in FIG. 28. Aright clamp element hole 138 in right clamp element 142 aligns with aleft clamp element hole (not visible) in left clamp element 144 whenclamp 137 is in a closed position as shown in FIG. 7. Clamp pin 128assembles through a clamp spring hole 136, right clamp element hole 138,the hidden left clamp element hole in left clamp element 144, and pinassembly hole 124 in block 102, to hold clamp 137 in the closedposition. When clamp 137 is held in a closed position, right frame 146and left frame 147 are held together as shown in FIG. 27.

Clamp 137 in FIG. 7 also includes a U-shaped, retainer wire 130 forinsertion into a pair of shaft retention holes 112 (only one shaftretention hole 112 is visible) in block 102. Right and left drivecables, 606 and 608, (not shown in FIG. 7) are retained in block 102 byretainer wire 130.

Turning briefly to FIG. 19, a side sectional view of head assembly 100reveals left drive cable 608 retained in block 102 by retainer wire 130engaging with ferrule indentation 656 of ferrule 660 of left drive cable608. Left shaft 650 is shown attached to left shaft connector 652, whichis operationally engaged on a left drive post 203 of left roller 197(partial view) for rotation and translation. Although not visible inFIG. 19, right drive cable 606 is attached in a similar manner to rightroller 196 and block 102.

Now referring to FIGS. 8 and 9, in the exploded isometric views, rightroller assembly 170 is shown in alignment with plow 290 and left helicalneedle 261. The following description for the right roller assembly 170is also descriptive of the left roller assembly, except that lefthelical needle 261 is driven in the opposite rotational direction ofright helical needle 260 in order to counteract the forces duringoperation within head assembly 100. The primary function of right rollerassembly 170 is to align and rotate helical needle 260 in the counterclockwise direction (looking proximal to distal) to drive helical needle260 through tissue. Each rotation of helical needle 260 constitutes astitch in the tissue, thus a running stitch may be made by multiplerotations of helical needle 260. Right helical needle 260 comprises aplurality of helical coils 264 and a tip 262 for penetration of tissue.In the free state, helical needle 260 appears circular when viewed froman end. When head assembly 100 is clamped onto tissue, helical needle260 appears slightly elliptical when viewed from the end because theneedle is held tightly between right roller 196 and plow 290 so that theneedle may be driven by rotation of right roller 196. Right roller 196comprises a plurality of annular grooves 198 spaced evenly apart. Aright drive post 202 extends from the proximal end of right roller 196for operational engagement with right drive cable 606 (not shown). Rightdrive post 202 has a non-circular cross section for rotationalengagement, and a tapered tip 204 for easy assembly. Right needle guide220 has a plurality of ribs 222 spaced evenly apart approximately thesame distance as the helical coils 264 on right helical needle 260. Eachindividual helical coil 264 projects between two adjacent ribs 222 so asto contact the inside of the corresponding one of a plurality of annulargrooves 198 in right roller 196. Right roller 196 is forcibly heldagainst helical needle 260 by leaf spring 190 sandwiched between rightroller housing 172 and right roller plate 192, which bears against rightroller 196. FIG. 8 shows the free state of right leaf spring 190, andFIG. 9 shows the assembled, compressed state of right leaf spring 190. Ashank 200 on right roller 196 rotates in a half-bushing 188 on rightroller housing 172. A roller end 206 is retained against the inside of aretaining arm 224 of right needle guide 220. Retaining arm 224 insertsinto a retention slot 180 and a retention hole 182 of right rollerhousing 172. Right needle guide 220 further includes a guide ramp 226and guide slot 227, which are instrumental in moving the upper pinassembly 430 (see FIG. 7) during operation as will be described.Similarly, right needle guide 220 includes a lower guide ramp 242 and alower guide slot 244, which are instrumental in holding the lower pinassembly 460 (see FIG. 3) during operation, as will be described later.

FIG. 10 is an isometric view of right roller assembly 170 containingright helical needle 260 in a start position, plow 290, and left helicalneedle 261, also in a start position. Plow 290, which is a means forincising at least one of the hollow organs so as to create a passagewaytherebetween, includes a plurality of left plow grooves 292 spacedevenly apart about the same distance as ribs 222 on right needle guide220. A plurality of left helical coils 263 are positioned in a likeplurality of left plow grooves 292. Similarly, a plurality of righthelical coils 264 are positioned in a like plurality of right plowgrooves (not visible). A plow blade 298 on the distal end of plow 290 isadapted to cut and separate tissue as plow 290 is translatedlongitudinally in the distal direction. Plow 290 includes a carriage 312having a right wing 306 and a left wing 304. When an operator actuatesthird actuator 602 (see FIG. 4) to translate right and left drivecables, 606 and 608, in the distal direction, right cable pushingsurface 660 (see FIG. 6) of right drive cable 606 pushes againstcarriage edge 291 of right wing 306 of carriage 312. Similarly, a leftcable pushing surface (not shown) pushes against carriage edge 291 ofleft wing 304. A right housing lip 178 assembles into a right wing notch310 of carriage 312. A left housing lip (not shown) assembles into aleft wing notch 308. When carriage 312 is pushed by right and left drivecables, 606 and 608, carriage 312 of plow 290 in turn pushes rightroller assembly 170 and left roller assembly 171 (FIG. 7) in the distaldirection. This moves right roller housing 172 (FIG. 7) and left rollerhousing 173 (FIG. 7) from an initial position to an operational positionfor joining the hollow organs together.

FIG. 11 is an exploded, isometric view of right tissue holder 330. Lefttissue holder 331 (see FIG. 7) is a mirror image of right tissue holder330. Right tissue holder 330 comprises a channel 349, and the followingelements, which are attached to channel 349, preferably by welding: anright upper spring latch 346, a right lower spring latch 348, an rightupper tissue clamp 332, and a right lower tissue clamp 334. Upper tissueclamp 332 locates into an upper channel recess 350 and has a pluralityof upper clamp flutes 354. Lower tissue clamp 334 locates into a lowerchannel recess 352 and has a plurality of lower clamp flutes 356. Awireform connector 336 inserts into channel hole 358 and a right framehole hidden from view in FIG. 11, and removably attaches channel 349 toright housing 146. Right tissue holder 330 further comprises rightneedle receiver 339, which includes a needle receiver bracket 338 and aneedle holder 340. Needle holder 340 includes a right post 342 and ahead 341, which is attached, preferably by welding, to needle receiverbracket 338. Right needle receiver 339 is removably retained in righttissue holder 330 by upper spring latch 346 engaging a bracket arm 344of needle receiver bracket and lower spring latch 348 engaging a bracketedge 343 of needle receiver bracket 338, so that post 342 of needlereceiver 339 is in the path of right helical needle 260 as shown inFIGS. 12 and 13.

FIG. 12 shows the alignment for assembly of right tissue holder 330 andright roller assembly 170 to right frame 146. (Left tissue holder 331and left roller assembly 171 assemble to left frame 147 in the identicalmanner.) A housing rail 174 on right roller housing 172 slides into aframe slot 151 of right frame 146, permitting right roller housing 170to move freely along shelf 156 of right frame 146. In FIG. 13, rightroller housing 170 is positioned in the initial position, which is themost proximal position, and retained in right frame 146 by attachingright tissue holder 330 to right frame 146 by wireform 336 intoelongated hole 150, channel hole 358, and the hole hidden from view onright frame 146. Right frame 146 includes an upper tissue pin slot 160and a lower tissue pin slot 158, which helps retain upper pin assembly430 to right frame 146.

FIG. 14 is a cross sectional view, taken along line 14—14 of FIG. 2, ofhead assembly 100. Right frame 146 and left frame 147 are shown heldtogether in the closed position. Plow 290 is shown in the center and isengaged with right helical needle 260 and left helical needle 261. Rightand left helical needles, 260 and 261, are shown to be out of phase.That is, right helical needle 260 is slightly more distal in thelongitudinal direction than left helical needle 261. The right and leftroller assemblies, 170 and 171 (see FIG. 10), are offset longitudinallyby half the distance between ribs 222 on needle guide 220, and anvil 290is configured to match this offset, so that stitches created on theright side of the hollow organs joined together are not directly opposedby stitches on the left side. Also shown in cross section in FIG. 14 arethe following: right and left roller housings, 172 and 173; right andleft leaf springs, 190 and 191, right and left roller plates, 192 and193; right and left rollers, 196 and 197; and right and left needleguides, 220 and 221. Right turret 148 of right frame 146 and left turret149 of left frame 147 are shown together as they would be held by clamp147 (not shown) as described for FIG. 7.

FIG. 15 is an exploded isometric view of upper pin assembly 430, whichcomprises an upper tissue pin 360, a spring plate 400, a guide plate420, and a tissue holder 380, all of which are preferably made of astainless steel. Upper tissue pin 360 includes a pin platform 368 at itsdistal end having a right flange 366, a left flange 365, a right ridge405, a left ridge 406, and a central flat 367. Upper tissue pin 360further includes a plurality of upper pin slots 361 on a middle region359, an insertion region 362, a pin tip or distal end 363, and an upperpin channel 364 running longitudinally through the entire length ofupper tissue pin 360. Spring plate 400 includes a bridge 404, a rightand a left spring stop, 403 and 401, extending from one side of bridge404, and a spring arm 402 extending from the same side of bridge 404 andbetween right and left spring stops, 403 and 401. Spring arm 402 isattached, preferably by welding, to flat 367 of platform 368 of tissuepin 360, and is spring biased to be in a normally up position as shownin FIG. 19. Right and left spring stops, 403 and 401, hit upon right andleft ridges, 405 and 406, to limit the upper position of tissue pin 360.Tissue holder 380 comprises a holder arm 381 and a cuff 382. Holder arm381 attaches, preferably by welding, to spring arm 402. Cuff 382 assistsin holding the open end of one of the hollow organs to be anastomosedduring the sequence of operation, as win be described later. Guide plate420 comprises a guide plate extension 424, which is attached, preferablyby welding, to bridge 404 of spring plate 400. Guide plate 420 furthercomprises a cut-out 422 to provide clearance for tissue pin 360 to moveto the up position. FIG. 16 is an isometric view of the assembled uppertissue pin 430, shown as the tissue pin 360 would be oriented when in adown position.

FIG. 17 is an isometric view of lower pin assembly 460, which comprisesa lower tissue pin 440, a pin support 466, right rail 490, and left rail491, all of which are preferably made from stainless steel. Right rail490 inserts into right rail hole 468 and is preferably welded together.Left rail 491 inserts into left rail hole 467 and is also preferablywelded together. Pin support 466 includes a support arm 462 having asupport arm ramp 469 and a support extension 464. Lower pin 440comprises a lower pin base or proximal end 449, which is attached,preferably by welding, to support extension 464. A right finger 447 anda left finger 448 extend from the sides of lower pin base 449. Lower pin440 further comprises a plurality of lower pin slots 443 on a lower pinmiddle region 441, an lower pin insertion region 444, a lower pin tip ordistal end 445, and a lower pin channel 446 extending through the lengthof lower pin 440. FIG. 18 is an isometric view of the lower pin assembly460 shown in FIG. 17.

FIGS. 19-28 show various steps of the operational sequence for thepresent invention. FIG. 19 is a side view of working portion 20 (seeFIG. 2) of the present invention, but with left frame 147 and leftroller assembly 171 (except for left helical needle 261) removed. Headassembly 100 is shown in the first position spaced apart from lowertissue pin assembly 460. Upper tissue pin 360 is shown in the upposition and inclined relative to the longitudinal axis of head assembly100. Although not apparent in FIG. 19, head assembly 100 is in theclosed position (a top view of head assembly 100 is also shown in theclosed position in FIG. 26). Right roller housing 172 is in the initial(furthest to the right) position. Left helical needle 261 is shown inthe start (furthest to the right) position. A first vessel 702, alsoreferred to as a first hollow organ, is shown in phantom view positionedonto upper tissue pin 360. First vessel 702 may, for example, be aharvested vein or artery from the patient. A second vessel 704, alsoreferred to as a second hollow organ, is shown in phantom viewpositioned onto lower pin assembly 460. As disclosed in U.S. Pat. No.6,015,416, upper and lower tissue pins, 360 and 440, may be penetratedinto the respective vessels after a surgical cutting instrument (notshown) is first used to create a tiny incision in the vessel. Secondvessel 704, which may be a stenosed coronary artery, is shown stillattached to an organ 700, which may be the heart of a surgical patient.Cuff 380 is shown clasping around the posterior side and near an openend 703 of first vessel 702 to help hold open end 703 during theoperational sequence. Left drive cable 608 is shown attached to headassembly 100 by retainer wire 130 engaging with ferrule indentations656. Left shaft 650, which translates in the distal direction and thenrotates in the counter clockwise direction during the operationalsequence, is initially stationary for this step. Left drive connector652, attached to left shaft 650, abuts against carriage edge 291 of plow290. Left drive connector 652 is also rotationally attached to leftdrive post 203 of left roller 197. Similarly, right drive cable 606(hidden behind left drive cable 608) is operationally engaged with plow290 and right roller 196 (also hidden). Clamp pin 128 is fully engagedwith clamp 137 of block assembly 132 and holding together left and rightframes, 146 and 147 (see FIG. 26), in the closed position. Left suture281 is shown trailing behind left needle 261 and exiting through block102. Right suture 280 (not shown) trails right needle 260 (hidden inthis view) and also exits block 102. Both sutures, 280 (not shown inFIG. 19) and 281, extend freely from head assembly 100 during theoperational sequence, and are drawn into head assembly 100 as right andleft helical needles, 260 (hidden in FIG. 19) and 261, are advanced andpenetrated into first and second vessels, 702 and 704.

FIG. 20 is a similar view as FIG. 19 showing the next step in theoperational sequence. Head assembly 100 is lowered into the secondposition so that lower pin assembly 460 and a portion of second vessel704 are aligned within head assembly 100. Lower clamp flutes 356 oflower clamp 334 press against the sides of second vessel 704. Secondvessel 704 is now held directly in the path of right and left helicalneedles, 260 (hidden) and 261. Second vessel 704 is normally attached toorgan 700, and is relatively immobile. Therefore, the operator lowershead assembly 100 close to organ 700 by actuation of first actuator 506(not shown) as described earlier for FIG. 2. Upper tissue pin 360 andfirst vessel 702 remain in the up position. First and second helicalneedles, 260 (hidden) and 261, remain in the start position. Rightroller assembly 170 remains in the initial position.

FIG. 21 is a similar view as FIG. 20 showing the next step of theoperational sequence. Plow 290 is now shown moved from a proximalposition (as shown in FIG. 20) to an intermediate position. Plow blade298 of plow 290 is immediately proximal to first and second vessels, 702and 704. The operator moves plow 290 to the intermediate position by theinitial actuation of third actuator 602 (not shown) on drive unit 600 asdescribed for FIG. 4, causing right and left shafts, 649 (hidden) and650, to translate in the distal (left) direction. As already described,translation of fight and left shafts, 649 and 650, advances right andleft roller assemblies, 170 and 171(not shown), from the initialposition to a middle position, still proximal to first and secondvessels, 702 and 704. As described for FIG. 8, right roller housing 172has guide ramp 226 and guide slot 227, and left roller housing 173 (notshown in FIG. 21, see FIG. 7) has a similar ramp and guide slot. Asright and left roller housings, 172 and 173 (not shown in FIG. 21)advance to the middle position, right and left flanges, 366 (hidden) and365, of upper pin assembly 430 (more clearly depicted in FIG. 15), arecaptured in guide ramp 226 (hidden), then guide slot 227 of right rollerhousing 172, and simultaneously in the guide ramp and slot of leftroller housing 173, causing upper pin assembly 430 to move to the downposition. Operation of actuator 602 causes the distal ends 363 and 445adjacent to one another. Consequently, upper tissue pin 360 and firstvessel 702 are moved into the down position within head assembly 100 sothat first vessel 702 is aligned parallel and tightly against secondvessel 704, and in the path of right and left helical needles, 260(hidden) and 261. Upper clamp flutes 354 of upper clamp 332 push againstfirst vessel 702 to hold it in place. Plurality of upper pin slots 361of upper tissue pin 360 are aligned with plurality of lower pin slots443 of lower tissue pin 440, thus becoming guides within the lumens offirst and second vessels, 702 and 704, for first and second helicalneedles, 260 and 261.

FIG. 22 is a similar view as FIG. 21, showing the next step of theoperational sequence. The operator completely actuates third actuator602 (not shown) on drive unit 600 as described for FIG. 4, thus causingfirst and second shafts, 649 (hidden) and 650, to translate further inthe distal (left direction). As a result, plow 290 advances to a distalposition and plow blade 298 cuts a passageway between first and secondvessels, 702 and 704. As plow 290 advances it pushes right and leftroller assemblies, 170 and 171 (not shown), to an operational positionalongside of first and second vessels, 702 and 704. Plow grooves 292 ofplow 290 align with upper pin slots 361 of upper tissue pin 360 andlower pin slots 443 of lower tissue pin 440, to form a path for rightand left helical needles, 260 (hidden) and 261.

FIG. 23 is similar view as FIG. 22, showing the next step of theoperational sequence. The operator actuates fourth actuator 604 (notshown) to rotate first and second shafts, 649 (hidden) and 650, inopposite directions as described for FIG. 4. Right and left helicalneedles, 260 (hidden) and 261, rotate and advance within head assembly100 and through first and second vessels, 702 and 704, creating a stitchthrough them with each full rotation. As a plurality of left suturestitches 708 are completed, left helical needle 261 winds onto a leftpost 345 of left needle receiver 333. Similarly, right helical needle260 winds onto right post 342 (hidden) of right needle receiver 330(hidden), creating a plurality of right suture stitches 706 (hidden inFIG. 23).

FIG. 24 is a cross-sectional view of head assembly 100 taken along line24—24 of FIG. 23. Right and left helical needles, 260 and 261, arepenetrated through first and second vessels, 702 and 704, which are heldtightly by right upper tissue clamp 332, right lower tissue clamp 334, aleft upper tissue clamp 313, and a left lower tissue clamp 315. Upperpin channel 364 of upper tissue pin 360 is captured on upper plow rail296 of plow 290. Lower pin channel 446 of lower pin 440 is captured onlower plow rail 294 of plow 290. The severed edges of first and secondvessels, 702 and 704, are partially inverted due to the shape of plow290. When right and left sutures, 280 and 281, are tied together as willbe described for FIG. 30, first and second vessels, 702 and 704,preferably become joined intima-to-intima so that endothelial cells caneasily grow over their junction and form a smooth inner lining of thevessels.

FIG. 25 is similar view as FIG. 23, showing the next step in theoperational sequence. Left helical needle 261 is completely wound ontoleft post 345 of left needle receiver 333. Similarly, right helicalneedle 260 (hidden) is completely wound onto right post 342 (hidden) ofright needle receiver 330 (hidden). Right and left sutures, 260 (hidden)and 281, now join first and second vessels, 702 and 704, togetherloosely, and will be further tightened manually after head assembly 100is removed.

FIG. 26 is a top view of head assembly 100 (shown without first andsecond vessels, 702 and 704) with right frame 146 and left frame 147held together in the closed position by clamp pin 128 in block assembly132. Right and left helical needles, 260 and 261, are partially visibleand are in the start position. Plow 290 is partially visible and is inthe proximal position. Right roller assembly 170 and left rollerassembly 171, are partially visible and are in the initial position.

FIG. 27 is the same view as FIG. 26, showing head assembly 100 (againwithout first and second vessels, 702 and 704). Left helical needle 261is completely contained in left needle receiver 333 such as alsodepicted in FIG. 25. The operator may use a surgical tool 800 to graspneedle receiver 333 and release it from a left upper spring latch 347and a left lower spring latch 351 of head assembly 100. Left suture 281is simultaneously drawn through head assembly 100 (and vessels, 702 and704, if they were contained in head assembly 100). Left helical needle261 and left needle receiver 333 are cut from left suture 281 using asurgical cutting tool such as a scalpel or scissors. The operator musttake care to provide enough free length of suture extending from headassembly 100 for tying a knot later. Similarly, right helical needle 260is removed from head assembly 100 by using surgical tool 800 to graspneedle receiver 330 and release it from right upper spring latch 346 andright lower spring latch 348 of head assembly 100. Right suture 280(hidden) is drawn through head assembly 100 (and vessels 702 and 704 ifthey are contained in head assembly 100). Helical needle 260 and rightneedle receiver 330 are removed by cutting right suture 280 (hidden inFIG. 27) with the surgical cutting tool, again taking care to provide asufficient length of suture extending from head assembly 100 for knottying later.

FIG. 28 is a top view of head assembly 100 in the open position. (Rightand left needle receivers, 330 and 333, have been removed from headassembly 100 as described for FIG. 27.) The operator manually retractsrelease pin 128 to allow right frame 146 and left frame 147 to springapart to the orientation depicted. The operator may next move headassembly 100 in the proximal (upward, as viewed in FIG. 28) direction toremove upper and lower tissue pins, 360 and 440, from the lumens offirst and second vessels, 702 and 704, respectively.

FIG. 29 is a top view of first and second vessels, 702 and 704,immediately after head assembly 100 has been removed as described forFIG. 28. First and second vessels, 702 and 704, are loosely heldtogether by a plurality of right and left suture stitches, 706 and 708,of right and left sutures, 280 and 281, respectively.

FIG. 30 is a similar view as FIG. 29, showing a partially tied distalknot 710 and a partially tied proximal knot 712 in right and leftsutures, 280 and 281. Distal knot 710 is first tied under first vessel702 by applying a plurality of conventional, alternating suture throws.Proximal knot 712 is then tied over first vessel 702 by applying aplurality of conventional, alternating suture throws, thus closing openend 703 of first vessel 702. As proximal knot 712 is drawn together,plurality of right and left suture stitches, 706 and 708, are tightenedto hold first and second vessels, 702 and 704, tightly together andsealing around the edges of the newly created passageway between them.The unneeded portions of right and left sutures, 280 and 281, are thentrimmed off using a surgical cutting tool and the anastomosis iscompleted. The operator may also tie the knots in the reverse order,that is, proximal knot 712 may alternatively be tied before tying distalknot 710.

FIG. 31 is a sectional view of a prior art needle 670 conventionallyattached to a suture 672. As is well-known in the art, there are avariety of methods for attaching a surgical needle to a suture. FIG. 31depicts one method in which needle 670 having a needle hole 675 iscrimped directly over suture 672. When suture 672 is pulled in adirection non-parallel to the longitudinal axis of needle 670, there isa stress concentration at a corner edge 673 of needle hole 675. Withsufficient force, the strength of suture 672 is exceeded and suture 672breaks next to corner edge 673.

FIG. 32 is a cross-sectional view of left helical needle 261 of thepresent invention. A stress relieving element 674 covers left suture 281inside a left helical needle hole 671 and extending outside hole 671 ashort (1-3 mm, for example) distance. Stress relieving element 674provides an interface between needle 261, which may be made of, but isnot limited to, a stainless steel, and suture 281, which may be made of,but is not limited to, a polymer or organic material that is much softerthan stainless steel. Stress relieving element 674 is preferably aflexible plastic. A suitable material for stress relieving element 674is a high performance, medical grade, natural colored, polyimide tubing(code 030-I) that is available from MicroLumen, Inc., 7930 WoodlandCenter Blvd., Tampa, Fla. U.S.A. 33614. The inner diameter of the 030-Ipolyimide tubing is 0.0031 inches (0.078 mm) and the wall thickness is0.00040 inches (0.010 mm). When left suture 281 is pulled in a directionnon-parallel to the longitudinal axis of needle 261, stress is not asconcentrated at corner edge 677 as for the stress at corner edge 673 ofthe prior art needle 670 in FIG. 31. Therefore, the maximum off-axispulling force that may be applied to suture 281 is much higher than forthe prior art needle/suture combination in FIG. 31, everything elsebeing equal. In the present invention, the stress relieving element 674is particularly useful during the repeated rotations of right and lefthelical needles, 260 and 261, through head assembly 100. Stressrelieving element 674, however, is not limited to use with the presentinvention, but is generally applicable to many other surgicalneedle/suture combinations.

While the applicant describes in this document a preferred embodiment ofthe present invention, it will be obvious to those skilled in the artthat the applicant provides such an embodiment as an example only.Numerous variations and substitutions will now occur to those skilled inthe art without departing from the spirit and scope of the appendedclaims.

What is claimed is:
 1. A surgical device for presenting a first holloworgan and a second hollow organ for creation a passageway therebetween,said surgical device comprising: a. a member, an upper pin for enteringa first hollow organ, and a lower pin for entering a said second holloworgan, said pins having proximal ends attached to said member, distalends extending therefrom and longitudinal axis extending therebetween;and b. a first actuator assembly coupled to said member for laterallymoving said distal and proximal ends of said lower pin relative to saidfirst member, and a second actuator coupled to said member for movingsaid distal ends of said upper and lower pins adjacent to one another soas to move said hollow organs close together.
 2. The device of claim 1further including a plow movably attached to said member between saidupper and lower pins, said plow is movable along said longitudinal axisof said pins to incise at least one of said hollow organs so as tocreate a passageway between said hollow organs.
 3. The device of claim 2further including a needle having a suture attached thereto, and a meansfor driving said needle through said organs, about said passagewaythereby attaching said hollow organs together.
 4. The device of claim 1wherein said first actuator for laterally moving said distal andproximal ends of said lower pin relative to said first member comprisesa movable arm having a distal end attached to said proximal end of saidlower pin, and a proximal end movably attached to said member such thatsaid arm can be spaced apart from said member or moved closely adjacentthereto.
 5. The device of claim 1 wherein second actuator for movingsaid distal ends of said upper and lower pins adjacent to one another soas to move said hollow organs close together comprises a pivot assemblyattaching said proximal end of said upper pin to said member.
 6. Thedevice of claim 1 further including a means for incising at least one ofsaid hollow organs so as to create a passageway between said holloworgans.
 7. The device of claim 6 further including a means for attachingsaid hollow organs together about said passageway.
 8. The device ofclaim 1 wherein said first actuator for laterally moving said distal andproximal ends of said lower pin relative to said member comprises amovable arm having a distal end attached to said proximal end of saidlower pin, and a proximal end movably attached to said member such thatsaid arm can be spaced apart from said member or moved closely adjacentthereto.
 9. The device of claim 1 wherein second actuator for movingsaid distal ends of said upper and lower pins adjacent to one another soas to move said hollow organs close together comprises a pivot assemblyattaching said proximal end of said upper pin to said member.
 10. Thedevice of claim 1 wherein said device includes two helical needles, eachhaving a suture attached thereto, one needle being laterally spaced oneither side of said plow, wherein said needle driver rotates saidhelical needles so as to drive them in a distal direction wherein saidneedles penetrate both of said organs thereby attaching said two organstogether by said sutures.
 11. A surgical device for attaching a firsthollow organ to a second hollow organ and creating a passagewaytherebetween, said surgical device comprising: a. a member, an upper pinfor entering a first hollow organ, and a lower pin for entering a saidsecond hollow organ, said pins having proximal ends attached to saidmember, distal ends extending therefrom and longitudinal axis extendingtherebetween; b. a first actuator coupled to said member for laterallymoving said distal and proximal ends of said lower pin relative to saidmember, and a second actuator coupled to said member for moving saiddistal ends of said upper and lower pins adjacent to one another so asto move said hollow organs close together; c. a plow movably attached tosaid member between said upper and lower pins, said plow is movablealong said longitudinal axis of said pins to incise at least one of saidhollow organs so as to create a passageway between said hollow organs;and d. a needle driver coupled to said member and a needle having asuture attached thereto, said needle driver drives said needle throughsaid organs, about said passageway thereby attaching said hollow organstogether.